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NCT05103046 | RECRUITING | Advanced Solid Tumor

First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors
Sponsor:

1200 Pharma, LLC

Brief Summary:

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced solid tumors.

Condition or disease

Advanced Solid Tumor

Intervention/treatment

UCT-03-008

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 68 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, First in Human, Dose-Escalation Study of UCT-03-008 in Participants With Advanced Solid Tumors
Actual Study Start Date : 2021-12-23
Estimated Primary Completion Date : 2024-12-15
Estimated Study Completion Date : 2025-12-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Advanced solid tumor
  • * Measurable disease, per RECIST v1.1
  • * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • * Adequate organ function
Exclusion Criteria
  • * Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
  • * Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of UCT-03-008
  • * Progressive or symptomatic brain metastases
  • * Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
  • * History of significant cardiac disease
  • * History or current evidence/risk of retinopathy
  • * History of myelodysplastic syndrome (MDS) or AML
  • * History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
  • * If female, is pregnant or breastfeeding
First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors

Location Details

NCT05103046

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

UCLA - JCCC Clinical Research Unit

Los Angeles, California, United States, 90095

TERMINATED

United States, California

Torrance Memorial

Torrance, California, United States, 90505

TERMINATED

United States, Georgia

Winship Institute of Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Texas

Mary Crowley Cancer Research

Dallas, Texas, United States, 75230

TERMINATED

United States, Texas

START (South Texas Accelerated Research Therapeutics)

San Antonio, Texas, United States, 78229